Search Results
Found 1 results
510(k) Data Aggregation
K Number
K121264Device Name
TRITON ELECTRIC HIGH TORQUE HANDPIECE AND SOFTWARE MODULE
Manufacturer
MEDTRONIC SURGICAL TECHNOLOGIES
Date Cleared
2012-08-27
(123 days)
Product Code
HBE, HBC, HRX, HWE
Regulation Number
882.4310Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC SURGICAL TECHNOLOGIES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IPC System with the TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.
Device Description
The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.
Ask a Question
Page 1 of 1